Kappa, Rhodamine, Antigen, Antiserum, Control

FDA classification

FDA Class 2 ·Kappa, Rhodamine, Antigen, Antiserum, Control

COSGROVE DEPTH ELECTRODE KIT(CDEK)

FDA 510(k)

FDA Class 2 ·Neurology

EYESOPEN TONOMETER

FDA 510(k)

FDA Class 2 ·Ophthalmic

UTERMOHLEN CRYO PROFESSIONAL

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mL

FDA 510(k)

FDA Class 2 ·Microbiology

Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml

FDA 510(k)

FDA Class 2 ·Microbiology

LEGACY MEDICAL ECO-CHOICE DISPOSABLE BLOOD PRESSURE CUFF

FDA 510(k)

FDA Class 2 ·Cardiovascular

AC3 Series Intra-Aortic Balloon Pump (IABP)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SINGLE USE ESOPHAGEAL MANOMETEY CATHETERS AND SINGLE USE ANO-RECTAL MANOMETRY CATHETERS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MS-39

FDA 510(k)

FDA Class 2 ·Ophthalmic

Wishbone HA

FDA 510(k)

FDA Class 2 ·Dental

END 200 Endoscopic Tubeset

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EZ PLUS IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

EndoFLIP® System with FLIP Topography module

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EsoFLIP® ES-310 Balloon Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DESS Dental Smart Solutions

FDA 510(k)

FDA Class 2 ·Dental

DESS Dental Smart Solutions

FDA 510(k)

FDA Class 2 ·Dental

DESS Dental Smart Solutions

FDA 510(k)

FDA Class 2 ·Dental